Clearance Summary
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC received FDA 510(k) clearance under submission number K111692, sponsored by Somatex Medical Technologies GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2011-11-08.
- Submission: K111692
- Applicant / Sponsor: Somatex Medical Technologies GmbH
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2011-11-08
Classification & Regulation
This clearance is catalogued under FDA product code NEU and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.